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Pharmacovigilance System Master File (PSMF) Management

Experience in European Markets to Expertly Maintain the Pharmacovigilance System Master File

With their deep understanding of EU regulations, our pharmacovigilance specialists provide all the necessary support to prepare and maintain the PMSF under GVP Module II. We leverage our experience and presence in Europe to expertly maintain the pharmacovigilance system master file in compliance with EU Directive 2010/84/EU (amending 2001/83/EC)

Our Services Include:

  • Preparation of the PMSF Template
  • Verification and Update of the PMSF Content, Including but Not Limited to:
    • Details of the QPPV
    • Organization Structure of the Marketing Authorization Holder
    • Safety Data Sources
    • Pharmacovigilance Systems And Databases
    • System Performance and Processes
  • Creation of Additional Annexes as Required
  • Authoring of SOPs for PSMF Maintenance
  • Creation of Training Material